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Range of approvals in Japan

Several major drug companies, including Merck, GSK and Novartis have had marketing approvals in Japan for products in a variety of therapy areas including COPD, bipolar disorder and cancer

Several major drug companies, including Merck, GlaxoSmithKline (GSK) and Novartis have had marketing approvals in Japan for products in a variety of therapy areas including chronic obstructive pulmonary disease (COPD,) bipolar disorder and cancer.

Japan's body responsible for drug regulation, the Japanese Ministry of Health, Labour and Welfare, has approved three Merck products, including the human papillomavirus (HPV) vaccine, Gardasil, for the prevention of cervical cancer.

Merck's oral anticancer drug, Zolinza (vorinostat) was also approved, while the ministry announced antibacterial agent, Cubicin (daptomycin) could be used for the treatment of MRSA infections.

Elsewhere, Novartis received approval in Japan for Onbrez Inhalation Capsules (indacaterol) for the treatment of COPD. The treatment is already approved in the EU and is under review in the US.

GSK saw its Lamictal (lamotrigine) gain a new indication for the prevention of depressive episodes in adult patients with bipolar disorder. It is currently approved for treatment in patients with epilepsy whose condition is inadequately controlled by other antiepileptic drugs.

Nexium (esomeprazole magnesium), marketed by AstraZeneca (AZ), received regulatory approval in Japan for the treatment of certain acid-related conditions, including non-erosive reflux disease. AZ plan to launch the drug in the country in the second half of 2011.

Tokyo-based Astellas also received news of Japanese approvals, including Betanis (mirabegron) for use in the treatment of overactive bladder, and Recalbon (minodronic acid hydrate) for use in osteoporosis.

5th July 2011


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